Transcept Pharmaceuticals Announces Plan to Resubmit Intermezzo New Drug Application Following Meeting with the U.S. Food & Drug Administration

POINT RICHMOND, Calif., Sept. 14, 2011 /PRNewswire/ -- Transcept
Pharmaceuticals, Inc. (Nasdaq: TSPT) announced today its plan to
resubmit to the U.S. Food and Drug Administration (FDA) its New
Drug Application (NDA) seeking approval of Intermezzo®
(zolpidem tartrate sublingual tablet) for use as-needed for the
treatment of insomnia when a middle of the night awakening is
followed by difficulty returning to sleep.

The plan to resubmit the Intermezzo® NDA results from a
meeting today with the FDA during which the FDA generally agreed
with a Transcept proposal to reduce the recommended Intermezzo®
dose for women from 3.5 mg to 1.75 mg, and to keep the recommended
Intermezzo® dose for men at 3.5 mg. The Transcept
proposal also includes new instructions stating that
Intermezzo® should only be taken if patients have at least 4
hours of bedtime remaining, and that patients should refrain from
driving for at least 1 hour after arising and until 5 hours after
dosing Intermezzo®.

Based on discussion with the FDA, Transcept does not plan to
conduct additional studies prior to the resubmission of the
Intermezzo® NDA and expects to resubmit the Intermezzo® NDA
by the end of September 2011. The FDA has informed Transcept that
if the planned resubmission is adequately concise in summarizing
morning zolpidem levels and evidence that the levels are safe given
the proposed labeling, it may be able to consider the resubmission
as a two-month, Class 1 review under FDA guidelines. Transcept can
provide no assurance that the resubmission will be reviewed by the
FDA as a Class 1 resubmission or that the content of the
resubmission will be sufficient to support approval of
Intermezzo®.

Glenn A. Oclassen, President and Chief Executive Officer of
Transcept, stated "We are pleased that the FDA has expressed
general agreement with our proposal to address the concerns
expressed in the July 2011 Intermezzo® Complete Response
Letter. We look forward to working with the FDA to complete the
review of this important new treatment strategy for insomnia
characterized by middle of the night awakening."

About Transcept

Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical
company focused on the development and commercialization of
proprietary products that address important therapeutic needs in
the field of neuroscience. Transcept is developing Intermezzo®
(zolpidem tartrate sublingual tablet) as a prescription sleep aid
for use as needed when a middle of the night awakening is followed
by difficulty returning to sleep. Transcept and Purdue
Pharmaceutical Products L.P. have entered into a collaboration
agreement for the development and commercialization of
Intermezzo® in the United States. Transcept is also developing
TO-2061, a low dose ondansetron augmentation therapy for patients
with obsessive compulsive disorder (OCD) who have not adequately
responded to treatment with approved first-line pharmacotherapy.
For further information, please visit the Transcept website at:
www.transcept.com.

Forward Looking Statements

This press release contains forward-looking statements that
involve substantial risks and uncertainties. All statements, other
than statements of historical facts, included in this press release
are forward-looking statements. Examples of such statements include
our expectations around the timing for filing, the FDA
classification, and the associated FDA review period, for the
planned Intermezzo® NDA resubmission, and that the planned
resubmission will be deemed complete and accepted by the FDA; and
the sufficiency of the planned Intermezzo® NDA resubmission to
satisfy FDA concerns and support approval of Intermezzo® for
use in its intended indication. Transcept may not actually
meet these expectations and carryout these plans. Various important
factors that could cause actual events to differ materially from
the forward-looking statements that Transcept makes, include any
FDA deemed insufficiencies in the planned Intermezzo® NDA
resubmission package; success in our efforts to seek approval for
Intermezzo®; and the business of Transcept generally.
These and other risks are described in greater detail in the "Risk
Factors" section of Transcept periodic reports filed with the
Securities and Exchange Commission. Forward-looking statements do
not reflect the potential impact of any future in-licensing,
collaborations, acquisitions, mergers, dispositions, joint
ventures, or investments Transcept may enter into or make.
Transcept does not assume any obligation to update any
forward-looking statements, except as may be required by law.